SoftOx Solutions AS: SoftOx submits Phase 1 Clinical Trial Application under the European Defence Fund (EDF) Program

16 Oct 2025 12:26 CEST

SoftOx Solutions AS (“SoftOx”) is pleased to announce that its fully owned
subsidiary SoftOx Defense Solutions AS has formally submitted its Phase 1
Clinical Trial Application (CTA) to the Irish Health Products Regulatory
Authority (HPRA) for approval. The trial is part of the European Defense Fund
(EDF) program, which aims to develop inhaled pharmaceuticals as medical
countermeasures against biological warfare threats.

This submission represents the second CTA delivered by the SoftOx group within a
short period, marking another important milestone in the Company’s clinical
development strategy and execution capability.

The planned Phase 1 trial will evaluate the safety and tolerability of the
SoftOx Inhalation Solution (SIS) at higher concentrations to establish a broader
therapeutic window and support further clinical advancement as a medical
countermeasure.

Study start is expected in Q1 2026, subject to approval.

Successful progress and positive data from this study are expected to further
strengthen SoftOx’s strategic position as a developer of dual-use technologies —
addressing both civilian health needs and biological defense preparedness — and
enhance its attractiveness as a potential partner for global pharmaceutical
companies.

For more information, please contact:
Ulrik Spork, Chairman of the Board, SoftOx Solutions AS, +45 31 38 83 87
Thomas Bjarnsholt, CEO, SoftOx Solutions AS, +45 20 65 98 88
Mail: ir@soft-ox.com

About SoftOx Solutions AS:
SoftOx Solutions AS (ticker: SOFTX) is a clinical-stage pharmaceutical company
listed on Euronext Growth Oslo. The company is developing highly effective
pan-antimicrobial pharmaceuticals targeting bacteria, viruses, and fungi. The
technology is based on extensive research and development in partnership with
leading Nordic research institutes.

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